Zydus Launches World’s First Biosimilar of Adalimumab

Access to this therapy will impact 12 million people suffering from auto immune disorders like rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and Ankylosin Spondylitis in India

After more than a decade-long wait, the revolutionary therapy that provided a new lease of life to millions of patients suffering from rheumatoid arthritis and other auto immune disorders globally will now be accessible to patients in India. Zydus Cadila becomes the first company anywhere in the world to launch the biosimilar of Adalimumab – the world’s largest selling therapy. Developed by the researchers at the Zydus Research Centre, the biosimilar has been approved by the Drug Controller General of India and will be marketed under the brand name Exemptia, to treat auto immune disorders such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and Ankylosing Spondylitis.

This novel non-infringing process for Adalimumab and a novel non-infringing formulation have been researched, developed and produced by scientists at the Zydus Research Centre. The biosimilar is the first to be launched by any company in the world and is a ‘fingerprint match’ with the originator in terms of safety, purity and potency of the product. The biosimilar of Adalimumab is a part of Zydus’ robust biologics programme which has the largest number of monoclonal antibodies under development in India. The group’s R&D pipeline which comprises 24 biologics includes biosimilars and three novel biologics. These biologics are being developed to treat auto immune disorders like arthritis, cancer, infertility and stroke.

Adalimumab, the fully human anti-TNF alpha monoclonal antibody, was first approved globally in 2002 and has since then been the most preferred therapy to treat patients suffering from auto immune disorders. However, the therapy was not available to patients in India. It is estimated that more than 12 million patients in India suffer from these chronic conditions which progressively deteriorate and lead to lifelong pain and in some cases, even disability.

Speaking on the breakthrough, Deputy Managing Director of Zydus Cadila, Dr. Sharvil P. Patel said, “At Zydus, we believe that innovations must bridge unmet healthcare needs and provide solutions to patients who are suffering from disease and disability especially in such chronic conditions. This therapy will offer a new lease of life to millions in India who have not had access to this therapy so far. We are happy to offer them hope, freedom from pain and a better quality of life through Exemptia.”

Biosimilars are biological products that are ‘similar’ or ‘highly similar’ to the reference medicinal products (originator products) following the EMA (European Medicines Agency), FDA (Food and Drug Administration, USA) and the CDSCO regulatory guidelines. Biosimilars have a similar level of efficacy and safety compared to that of the originator products and provide additional advantage to patients in terms of affordability and accessibility.

Exemptia is given as a 40 mg subcutaneous injection once every alternate week. Patients normally would have to take the treatment for six months. It has been clinically observed that the therapy is able to arrest the degeneration and the patient goes into remission – which means the auto immune disorder is under control and the patient is able to live a life without pain and can actually lead a fully active life.